Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer

Summary

This is a phase II trial of adjuvant chemotherapy and immunotherapy for completely resected small cell lung cancer (SCLC).

Eligibility

Inclusion Criteria:

* Age ≥ 18 years.
* Body weight \>30 kg.
* Must have a life expectancy of at least 12 weeks.
* Must have histologically or cytologically confirmed diagnosis of pathologic T1-T2 N0-1 M0 small-cell lung cancer per the American Joint Committee on Cancer staging system, 8th edition.
* Have completely resected (wedge resection, segmentectomy, lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy) small-cell lung cancer within 78 days of enrollment.
* Complete mediastinal lymph node dissection (MLND) or systematic mediastinal lymph node sampling is required.
* No prior systemic therapies, for small cell lung cancer.
* Post-operative radiation for the resected small cell lung cancer is acceptable per treating physician in the setting of N1 disease, but no other prior radiation for small cell lung cancer.
* ECOG performance status 0-1.

Exclusion Criteria:

* Patients who are receiving any other investigational agents.
* Concurrent enrollment in another clinical study involving investigational treatment directed to treatment of patients with small cell lung cancer.
* Prior treatment with durvalumab.
* History of another primary malignancy except for:

  * Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence.
  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  * Superficial bladder cancer without active disease after treatment.
  * Low grade prostate cancer without indication for active treatment.
  * Adequately treated carcinoma in situ without evidence of disease.
* Patients with a history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 3 months.
* Patients with hemoptysis in excess of 2.5 mL within 2 weeks prior to the first dose of study medication.
* Patients requiring concomitant therapy with phenytoin, phenobarbital, or carbamazepine.

Conditions3

Locations1 site

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